AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Station

M

Mark_N

#1
Hi everybody!

Does anyone have any experience with 9110 and special processes in Repair Station? We are the repair station that maintains Boeing and Airbus aircraft up to and insluding D-Check (heavy maintenance). During this maintenance we can use repair procedures that are considered as special processes but these proceses are very "light" if compare with a manufacture.
For example:
- we use a soldering for the repair of landing lights to change the bulb,
- we use a heat treatment for rivets during repairs of aircraft structure,
- we perform a lot of NDT inspections,
- we strip a paint and re-paint aircraft and components,
- we crimp connectors during defect rectification related to wirings,
- we weld some cracks on thrust reverses doors.

All of these works we perform iaw approved maintenance data from TC holders - AMM, SRM, CMM etc.

I feel some doubts that our repair station shall do the same things as manufacturer, regarding the special processes.

I have checked existing manuals:
- Airbus has Process and Material Specification (PMS) that estables requirement for the proceses in whole, and SRM (structure repair manual) that provides detail instructions for particular work.
- Boeing has Standard Overhaul Practices Manual that provides detailed instructions for the processes and SRM (structure repair manual) that provides detail instructions for particular work.

For example, Heat Treatment: SRM describes the themperature ranges, time and tests for verification but nothing about furnace parameters for heat treatment. These parameters and quality requirement for the process in whole I found in PMS.

Airbus know well and use NADCAP for their suppliers-manufacturer but when I tried to ask Airbus about their policy related to the special processes (throuhg techrequest service) in the maintence - nobody could understand what does special process mean. EASA does not use the term "Special process", they use the term "Specialized works"
Thechnical manuals (AMM, SRM etc) do not use the term "Special process" also.

So, when we perform the works that can be considered as the special processes, we always do it strongly in compliance with approved instructions developed by TC Holder (Airbus or Boeing). We also do not fabricate any parts during repair.

My question - What procedures we have to develop additionally to be in compliance with AS9110 requirements?

Situation is very funny as all our maintenance managers know nothing about special processes and this repeats in all Repair stations that I know.
 
Elsmar Forum Sponsor
M

Mark_N

#2
Re: AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Sta

I really need advice :(
 

howste

Thaumaturge
Trusted Information Resource
#4
Re: AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Sta

My question - What procedures we have to develop additionally to be in compliance with AS9110 requirements?
Here are the requirements that need to be met:
AS9110 Rev C said:
8.5.1 Control of Production and Service Provision

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable... f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

NOTE: These processes can be referred to as special processes (see 8.5.1.2) complying with the requirements of the applicable technical data issued by the type certificate holder or acceptable to the competent authority.

8.5.1.2 Validation and Control of Special Processes

For processes where the resulting output cannot be verified by subsequent monitoring or measurement, the organization shall establish arrangements for these processes including, as applicable:
a. definition of criteria for the review and approval of the processes;
b. determination of conditions to maintain the approval;
c. approval of facilities and equipment;
d. qualification of persons;
e. use of specific methods and procedures for implementation and monitoring the processes;
f. requirements for documented information to be retained.
The short answer is, if all of these requirements are met by using the tech data provided by the Type Certificate Holder, then you don't need more procedures. If only some of these requirements are addressed in the TC Holder's documents, then you will need to define, document, and implement your own requirements to cover the missing ones.

For example, let's say you have a process with a document from the TC Holder that specifies criteria for the review and approval of the process, conditions to maintain approval, methods and procedures for implementing and monitoring the process, and required records. You would then need to determine and define requirements for approval of facilities and equipment and personnel qualification. You will need to look at each process and ensure that each process for each TC Holder has all bases covered.

An alternative would be to develop your own comprehensive procedures that meet all TC Holder requirements. These would need to be updated whenever TC Holder requirements are updated. It would be a lot of work, but would avoid confusion if you have different customers with different requirements for the same type of process.
 
M

Mark_N

#6
Re: AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Sta

Here are the requirements that need to be met:


The short answer is, if all of these requirements are met by using the tech data provided by the Type Certificate Holder, then you don't need more procedures. If only some of these requirements are addressed in the TC Holder's documents, then you will need to define, document, and implement your own requirements to cover the missing ones.

For example, let's say you have a process with a document from the TC Holder that specifies criteria for the review and approval of the process, conditions to maintain approval, methods and procedures for implementing and monitoring the process, and required records. You would then need to determine and define requirements for approval of facilities and equipment and personnel qualification. You will need to look at each process and ensure that each process for each TC Holder has all bases covered.

An alternative would be to develop your own comprehensive procedures that meet all TC Holder requirements. These would need to be updated whenever TC Holder requirements are updated. It would be a lot of work, but would avoid confusion if you have different customers with different requirements for the same type of process.
:thanks: I agree with you.

I had idea to get the list of special processes that are performed in maintenance from TH Holder. I asked Airbus to provide us such list (if they have it) or explain their policy regarding special processes in maintenance. However, they didn't understand what I ask. I know that Airbus has his special Rep in NADCAP and I asked Airbus to send this request to people/department who are responsible for special processes in Airbus - no reaction. I know, that some TC Holders have such list of special processes for old aircraft that still have old "Overhaul" philisophy.

I was hoping that if Airbus provided us with such list, it would greatly reduce the number of processes that we will consider as special.
 
Thread starter Similar threads Forum Replies Date
K Comparison: AS9110C vs. C.A.S.E. 1-A AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B How to satisfy clause 5.7.1.5 process validation for valve production API 6D Oil and Gas Industry Standards and Regulations 13
W IEC 60601-1 clause 8.8.3 - Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B IEC 60601-1 Clause 14.8 - Architecture IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
T API SPEC Q1 Clause 5.6.1.2.C).2) First Article Oil and Gas Industry Standards and Regulations 16
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Maximum Mains Voltage (clause 8.5.3) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
A ISO 14001:2015 clause 4.4 ISO 14001:2015 Specific Discussions 2
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
D PSW with waiver statement (hold harmless clause) IATF 16949 - Automotive Quality Systems Standard 3
Ashland78 MSA clause or wording needed. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A 60601-1 clause 8.11.3.6 Test Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S MSA clause 7.1.5.1.1 - Statistical studies on counting weight scale Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Thee Bouyyy Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 9
L ISO 45001:2018 - Clause 5.4: Consultation and Participation of Workers Process Maps, Process Mapping and Turtle Diagrams 1
V Clause 7.1.3.1 Plant, facility, and equipment planning Lean in Manufacturing and Service Industries 0
J Aluminum anodization as MOP insulation? Clause 8.5.1.1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
M IATF16949 Clause 9.1.2.1e - Customer notification related IATF 16949 - Automotive Quality Systems Standard 4
N 60601-2-2 Ed 6 Clause 201.8.8.3.102 - HF instrument leakage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H AS9100D clause 8.5.1 f) & 8.5.1 g) - Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
SANTHSH API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 12
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom